Sublimaze Side Effects

Generic Name: fentanyl citrate

Please note - some side effects for Sublimaze may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Sublimaze - for the Consumer

Sublimaze

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Sublimaze:

Anxiety; confusion; constipation; difficulty walking; dizziness; drowsiness; dry mouth; headache; indigestion; itching; nausea; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; fainting; hallucinations; muscle rigidity; seizures; severe or persistent dizziness, headache, or light-headedness; slow or irregular heartbeat; slow or shallow breathing; trouble breathing; weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Sublimaze Side Effects - for the Professional

Sublimaze

As with other narcotic analgesics, the most common serious adverse reactions reported to occur with Sublimaze (fentanyl citrate) are respiratory depression, apnea, rigidity, and bradycardia; if these remain untreated, respiratory arrest, circulatory depression or cardiac arrest could occur. Other adverse reactions that have been reported are hypertension, hypotension, dizziness, blurred vision, nausea, emesis, diaphoresis, pruritus, urticaria, laryngospasm and anaphylaxis.

It has been reported that secondary rebound respiratory depression may occasionally occur postoperatively. Patients should be monitored for this possibility and appropriate countermeasures taken as necessary.

When a tranquilizer is used with Sublimaze, the following adverse reactions can occur: chills and/or shivering, restlessness, and postoperative hallucinatory episodes (sometimes associated with transient periods of mental depression); extrapyramidal symptoms (dystonia, akathisia, and oculogyric crisis) have been observed up to 24 hours postoperatively. When they occur, extrapyramidal symptoms can usually be controlled with anti-parkinson agents. Postoperative drowsiness is also frequently reported following the use of neuroleptics with Sublimaze.

Cases of cardiac dysrhythmias, cardiac arrest, and death have been reported following the use of Sublimaze with a neuroleptic agent.

Side Effects by Body System - for Healthcare Professionals

Nervous system

Nervous system side effects have included mental and respiratory depression (particularly in the elderly), stupor, delirium, somnolence, and dysphoria. Muscle rigidity (involving the respiratory musculature including the glottis) may also occur and further aggravate the respiratory depression associated with fentanyl therapy. Myoclonus has been reported with the use of transdermal therapy. A case of severe hemiplegic migraine attack precipitated by fentayl sedation has also been reported.

Cases of seizures have occasionally been reported, but some investigators have suggested that the seizure-like events reported may have been episodes of fentanyl induced-rigidity.

Other

Fentanyl shares the potential for abuse associated with other narcotic analgesics. Cases of inhalation of the contents of fentanyl patches and oral ingestion of intravenous preparations have been reported.

Other side effects have included withdrawal symptoms (agitation, restlessness, anxiety, insomnia, tremor, abdominal cramps, blurred vision, vomiting, and sweating) after either abrupt cessation or fast tapering of narcotic analgesics.

Cardiovascular

Cardiovascular side effects have included hypotension, bradycardia, and arrhythmias rarely.

One report has suggested that epidural fentanyl may mask the pain of myocardial ischemia in patients treated with fentanyl for other reasons. Another report has suggested that QTc interval prolongation may occur in some patients receiving the related narcotic sufentanil. Another report has implicated fentanyl as a potential cause of pulsus alternans in a patient with aortic stenosis and congestive heart failure.

Nevertheless, fentanyl has been advocated by some as a satisfactory agent for coronary artery surgery.

Gastrointestinal

Gastrointestinal side effects including nausea, vomiting, and constipation have been reported to have occurred commonly. Dental decay of varying severity including dental caries, tooth loss, and gum line erosion have been reported. Choledochoduodenal sphincter spasm has been reported rarely.

Respiratory

Respiratory side effects have included respiratory depression which has been frequently observed with fentanyl therapy and one case of acute noncardiogenic pulmonary edema. Coughing has been reported following fentanyl administration for anesthesia induction.

Genitourinary

Genitourinary side effects including urinary retention have been reported for other narcotic analgesics. A case of priapism has been associated with fentanyl anesthesia.

Dermatologic

Dermatologic side effects have included pruritus which has been reported frequently. Localized rashes (associated with the use of transdermal fentanyl patches) and, less commonly, systemic rashes have also been reported.

Hypersensitivity

Hypersensitivity side effects including anaphylaxis have been reported rarely.

Hematologic

The hemolysis observed may have been related to rapid injection of large volumes of hypotonic fentanyl solution. The authors therefore recommend slower injection rates and/or mixture in isotonic fluid.

Hematologic side effects have included one study which suggested that a small amount of hemolysis (of uncertain clinical significance) may occur in patients treated with fentanyl.

Immunologic

Immunologic side effects including a case of recurrent herpes simplex infection have been reported following epidural administration of fentanyl. Intravenous fentanyl has been reported to increase natural killer cell cytotoxicity and circulating CD16+ lymphocyte levels.

Metabolic

Metabolic side effects including a case of syndrome of inappropriate antidiuretic hormone have been reported.

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